Efficacy and safety of sitagliptin as compared with glimepiride in Japanese patients with type 2 diabetes mellitus aged ≥ 60 years (START-J trial)

Yasuo Terauchi, Yuichiro Yamada, Hitoshi Ishida, Mitsuru Ohsugi, Masafumi Kitaoka, Jo Satoh, Daisuke Yabe, Nobuyuki Shihara, Yutaka Seino, Yasuo Terauchi, Yuichiro Yamada, Hitoshi Ishida, Mitsuru Ohsugi, Masafumi Kitaoka, Jo Satoh, Daisuke Yabe, Nobuyuki Shihara, Yutaka Seino

Abstract

The aim of this study was to evaluate the efficacy and safety of sitagliptin administered to elderly patients with type 2 diabetes mellitus (T2DM) for 1 year as compared with glimepiride. Patients aged ≥60 years with T2DM and inadequately controlled blood glucose were randomly assigned to sitagliptin 50 mg once daily or glimepiride 0.5 mg once daily for 52 weeks. The primary efficacy endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 52. Secondary efficacy endpoints included self-monitored blood glucose and weight. Safety endpoints were adverse events including hypoglycaemia. Administration of sitagliptin or glimepiride to elderly patients with T2DM resulted in a significant decrease in HbA1c change from baseline. At 52 weeks, the least squares mean difference between the treatments was 0.11% (95% confidence interval [CI] -0.02 to 0.24; P = .087) (1.2 mmol/mol [-0.2 to 2.6]). The upper limit of the CI was below the predefined non-inferiority margin (0.3% [3.3 mmol/mol]), demonstrating non-inferiority of sitagliptin to glimepiride for the primary endpoint. Sitagliptin resulted in a significantly lower incidence rate of non-serious hypoglycaemia than glimepiride during the 52 weeks (4.7% vs 16.1%; P = .002); thus, sitagliptin is a useful therapeutic option for elderly patients with T2DM.

Trial registration: ClinicalTrials.gov NCT01183104.

Keywords: DPP-4 inhibitor; clinical trial; randomized trial; sitagliptin; sulphonylureas.

© 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
LS mean changes in HbA1c (A) and body weight (B; LOCF) from baseline. The bars indicate standard errors. Numbers below the panels are number of patients
Figure 2
Figure 2
Incidence rates (%) of hypoglycaemia during 4‐week observation periods up to week 52, between weeks 52 and 78, and between weeks 78 and 104. Panel A shows the rates for sitagliptin and Panel B shows rates for glimepiride. Denominators are the number of patients who received at least 1 dose of study drug during each observation period. Morning, from breakfast to lunch; afternoon, from lunch to evening meal; night, evening meal to breakfast; W, week

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